Height Adjusted Versus Standardized Dose of Bupivacaine for Spinal Anesthesia (RAMCES)

Caen University Hospital

Status: Enrolling

Conditions: Cesarean Section Complications; Local Anesthetic Complication; Regional Anesthesia Morbidity

Treatments: Other: standardized dose; Other: adjusted dose

Study type: Interventional

Funder types: Other

Identifiers

NCT05233462

21-0217

Details and patient eligibility

About

General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section.

Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally.

To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.

Full description

The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section

• a "standard" dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms
• a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms

The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure.

Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled cesarean section with intrathecal anesthesia
• term pregnancy > 35 weeks
• signed informed consent

Exclusion criteria

• unscheduled or emergent cesarean section
• any contra indication to intrathecal anesthesia
• any antihypertensive drug prescribed to control arterial pressure during pregnancy
• pre-eclampsia and eclampsia
• history of Marfan or Ehlers Danlos disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

control group

Active Comparator group

Description:

intrathecal administration of a solution containing * bupivacaine 10 mg * morphine 100 micrograms * sufentanil 3 micrograms

Treatment:

Other: standardized dose

individualized group

Experimental group

Description:

intrathecal administration of a solution containing * bupivacaine 0.05 mg per cm of patient's height * morphine 100 micrograms * sufentanil 3 micrograms

Treatment:

Other: adjusted dose